International collaboration on GMP inspections – manufacturers of sterile medicines.

In December 2019, EMA and its European and international partners launched a pilot programme to share information on GMP inspections of manufacturers of sterile medicines located outside the participating countries and to organise joint inspections of manufacturing sites of common interest. The products in scope include sterile medicines for human use of chemical origin and certain therapeutic biotechnology -derived products, such as monoclonal antibodies and recombinant proteins. Vaccines, cell and gene therapies and plasma derived pharmaceuticals are currently out of the scope of this pilot. For the terms of reference, objectives and full scope.

This initiative builds on the success and experience with the API inspection programme.

See: https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-practice/international-collaboration-gmp-inspections

Posted by Dr. Tim Sandle, Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)